FDAClass IIMay 16, 2018

ADVIA Centaur¿ Cyclosporine recall

ADVIA Centaur¿ Cyclosporine

Why was ADVIA Centaur¿ Cyclosporine recalled?

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031

Product
ADVIA Centaur¿ Cyclosporine
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
N/A
Distribution
Nationwide and Canada, Mexico, and Thailand
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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